TGA approval for Atomo Diagnostics' COVID-19 diagnostic

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Atomo Diagnostics (ASX:AT1) has announced that the TGA has approved its rapid SARS-CoV-2 antibody blood test for use by medical professionals in Australia.

The approval means the AtomoRapidTM COVID-19 (IgG/IgM) test will now be added to Atomo’s existing Australian Register of Therapeutic Goods (ARTG) listing, alongside the Atomo HIV Self-Test.

Atomo said it will then commence supply of the test to departments of health, laboratories, medical practitioners and health care professionals in aged care facilities across Australia.

The AtomoRapidTM COVID-19 (IgG/IgM) test is jointly manufactured by Atomo and NG Biotech in France. NG Biotech manufactures the test strip and Atomo the device.

The Atomo test approved by the TGA is the same as the test that is already approved and being sold by NG Biotech in France.

Atomo Diagnostics co-founder and managing director John Kelly said, “Thanks to the TGA approval and the work of our dedicated team, we can now deliver what is in our view, a high-quality, reliable antibody rapid test to Australia.”

Mr Kelly added, “Atomo already sells Australia’s only approved HIV Self-Test and we know that our solution simplifies rapid blood-based testing in point-of-care settings. We are excited that our test can now be used in our
home market, Australia, to assist in the fight against the COVID-19 pandemic.”